Gilead Puts High Premium On Priority Review Voucher; Deal May Help Protect Lead In HCV
This article was originally published in RPM Report
Gilead pays $125 million for the right to a faster review of a future product, doubling the price paid in the first priority review voucher sale just months before. The value of the voucher may go up if pending legislation is signed into law – but the high price tag speaks volumes about the importance of maintaining the lead in Hep C formulation development.
You may also be interested in...
The recent series of sales of priority review vouchers at ever-higher prices has transformed what had seemed to be a failed incentive model into a hot topic. However, one key stakeholder is not celebrating the recent developments: the FDA review teams that have to deliver the faster paced reviews continue to have strong reservations about the program.
Company is returning focus to its HIV franchise, touting how a prodrug of tenofovir may help its HIV combos compete against other firms’ antivirals and hold off generics.
The approval of Retrophin/Asklepion’s Cholbam triggers the third pediatric rare disease priority review voucher – and the sunset provision in the statute authorizing the program.